A Randomized, Double-Blind, 12-Week, Dose-Ranging Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis

Conditions: Moderate to Severe Plaque Psoriasis
MedDRA version: 14.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2009-013037-19-DE

Lead Sponsor: Vascular Biogenics Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

1. Fully understand all elements of and have signed and dated the written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent before initiation of protocol-specified procedures;
2. Male or female Patients, =18 to =75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months;
3. Non-anorexic subjects with a BMI =20;
4. Psoriasis Area and Severity Index (PASI) score of =12;
5. Plaque psoriasis covering =10% of body surface area (BSA);
6. Psoriasis severity at least moderate, scoring at least 3 on a 0 to 5 point Physician Global Assessment (PGA) scale;
7. For a female subject; either:
- subject is of non-childbearing potential, defined as: menopause with amenorrhea >2 years, hysterectomy, or bilateral oopherectomy
or
- agrees to continue to use adequate contraception (implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence or vasectomised partner) throughout the study and for at least one month following termination and have a negative pregnancy test at screening and before the first dose of study drug;
Males must use at least one method of contraception (e.g., condom) throughout the study;

8. In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis;
2. Received any investigational drug within 30 days of screening;
3. The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline:
• Topical psoriasis treatments: 2 weeks
• Systemic psoriasis treatments: 4 weeks or 5 half-lives (whichever is longer);
• Phototherapy: 4 weeks
4. The subject anticipates getting enough ultra-violet light during the study (e.g. sunbathing; tanning salon, etc.) to cause psoriasis to improve;
5. The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation (see list of ingredients in the Investigator’s Brochure);
6. Any other acute or chronic medical condition that, in the opinion of the investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the study;
7. Patients with any laboratory test at screening that common medical practice would deem as significantly abnormal. The following will be deemed as significantly abnormal:
• alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase =1.5 times the upper limit of normal (ULN) or
• cytopenia (to include any of the following: WBC <3.5x1000/µL; Hgb <10 g/dL; platelets <120x1000/µL; neutrophils absolute <1.5x1000/µL; lymphocytes absolute <0.8x1000/µL) or
• Creatinine =1.25 times the upper limit of normal (ULN);
If, in the investigator’s opinion, there is no reason for the test result(s) to be abnormal, the abnormal test(s) may be repeated once during the screening period.
8. History of cancer, the exception is skin cancer, see below.
• Patients with >3 previous squamous cell skin cancer lesions are excluded
• Patients who had histologically controlled excision of basal cell and/or squamous cell carcinoma of the skin and have been declared to have no evidence of tumor can be enrolled
• Patients who had basal cell and/or squamous cell carcinoma of the skin removed and have not met these criteria can be enrolled if the skin cancer was removed >3 years prior to study participation and there is no evidence of recurrence;
9. Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis);
10. Evidence of tuberculosis as indicated by a positive tuberculin skin test (defined as =10 mm induration) or a quantiferon test in subjects known to have a + PPD and a negative chest x-ray at screening or prior to screening;
11. History of substance abuse, including alcohol abuse, within the past year;
12. Has a history of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR) [Exception; Patients with depression that has been adequately controlled for at least 6 months may enroll in the study];
13. History of clinically significant hypoglycemia;
14. Subjects with currently active peptic ulcer or gastroesophageal reflux disease;
15. Fem